Cleared Traditional

K153074 - Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

K153074 is an FDA 510(k) clearance for Kangaroo Connect Enteral Feeding Pump w..., manufactured by Covidien. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K153074 · Covidien · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
258d
Days
Class 2
Risk

K153074 is an FDA 510(k) clearance for the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kan.... Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on July 6, 2016 after a review of 258 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153074

510(k) Number K153074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date July 06, 2016
Days to Decision 258 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 129d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 28
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K153074.
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154 · Zevex, Inc. · Feb 2014